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Effectiveness of custom made insoles in athletes with patellofemoral pain; a randomized controlled trial.

Effectiveness of custom made insoles in athletes with patellofemoral pain; a randomized controlled trial. - Effectiveness of insoles in athletes with patellofemoral pain

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON37189
Enrollment
80
Registered
2013-01-24
Start date
2012-11-01
Completion date
Unknown
Last updated
2024-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

anterior knee pain chondromalacia patellae

Interventions

80 participants will be randomly assigned to the treatment or placebo group. Both groups will receive a home-based exercise program. In addition, the treatment group receives custom-made insoles and

Sponsors

Universitair Medisch Centrum Groningen
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - Age 18-40 years - athletes sporting at least three hours a week pre-injury - clinical diagnosis of patellofemoral pain syndrome: insidious onset of anterior or retropatellar knee pain lasting longer than six weeks and provoked by at least two of the following activities: prolonged sitting or kneeling, squatting, running, hopping/jumping, climbing stairs; tenderness upon palpation of the patella, and worst pain over the previous week of at least 3 out of 10 on a 10-point numerical rating scale.

Exclusion criteria

Exclusion criteria: - A traumatic origin - Concomitant injury or pain form the hip, lumbar spine, or other knee structures (like intra-articular pathology of the knee, Osgood Schlatter*s disease, bursitis and patellar tendinopathy) - Previous knee surgery - Patellofemoral instability - Knee joint effusion - Previous treatment with insoles or physiotherapy in the preceding 12 months

Design outcomes

Primary

MeasureTime frame
General pain severity over the preceding week after 12 weeks from baseline, measured on a numeric rating scale (NRS).

Secondary

MeasureTime frame
- experience of pain (using a NRS) and impairment (using a Likert scale) on activities of daily living, on work/study and on sporting activities over the preceding week - self-reported recovery (using a Likert scale) - functional disability (using the Anterior Knee Pain scale) - participants pain experience (using two questionnaires: SCL-90 and POMS) - satisfaction with the custom-made insoles based on comfort

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)